Lymphoedema of Leg
Conditions
Brief summary
The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.
Detailed description
The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the LymphAssist (Huntleigh Healthcare), against older sequential models. The study methodology consists of a pilot randomised control trial of two groups - Intervention group A will continue to receive their standard lymphoedema care but will also be provided with a LymphAssist IPC device to use, mimicking manual lymph drainage therapy. Participants in intervention group B will receive their standard care plus an IPC device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only. Outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.
Interventions
Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
Sponsors
University of South Wales
Cwm Taf University Health Board (NHS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 or over, * Able to provide written consent, * Confirmed diagnosis of lower limb ISL stage II or III.
Exclusion criteria
* • Unable to provide written consent * Severe congestive heart failure * Severe skin problems, lower limb ulcers or wounds. * Presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the IPC device safely or adhering to instructions/study protocol. * Non-pitting chronic lymphoedema. * Known or suspected deep vein thrombosis. * Pulmonary embolism. * Thrombophlebitis. * Acute inflammation of the skin (erysipelas, cellulitis). * Uncontrolled/severe cardiac failure. * Pulmonary oedema. * Ischaemic vascular disease. * Active cancer diagnosis. * Active metastatic diseases affecting the oedematous region. * Oedema at the root of the extremity or truncal oedema. * Severe peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Volume | 5 weeks | Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myoton Scores | 5 weeks | The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D) |
| Quality of Life Scores | 5 weeks | The effect IPC has on quality of life scores - raw score created from a series of Likert Scales |
Countries
United Kingdom
Outcome results
None listed